Power Medical Interventions(r) Receives 510(k) Clearance to Market iDrive Intelligent...
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Power Medical Interventions(r) Receives 510(k) Clearance to Market iDrive
Intelligent Power Unit(tm) With iConsole(tm)
LANGHORNE, Pa., May 27, 2009 (GLOBE NEWSWIRE) -- Power Medical Interventions(r),
Inc. (OTCBB:PMII), a leader in developing and commercializing Intelligent
Surgical Instruments(tm), announced today that the U.S. Food and Drug
Administration (FDA) has cleared its 510(k) application for marketing its iDrive
Intelligent Power Unit(tm), detachable Intelligent Surgical Instruments and
iConsole(tm). Based on the marketing clearance by the FDA, Power Medical
Interventions (PMI) intends to launch the iDrive, Intelligent Surgical
Instruments and iConsole products for commercial sale, effective immediately.
A first-of-its-kind breakthrough in operating room instrumentation, the iDrive
is designed to support a variety of minimally invasive procedures by offering
surgeons a broad range of cutting and stapling configurations combined with
increased flexibility, access and precision. The iDrive is a novel hand-held,
computer-controlled power unit to which any of the company's Intelligent
Surgical Instruments can be attached. This innovation allows all of PMI's
Intelligent Surgical Instruments to be driven by a single power unit. As a
result, hospitals will be able to acquire PMI's advanced technology platform at
less than half of the current cost, which may lead to significant savings for
hospitals. The potential now exists for a comprehensive surgical solution that
may be significantly less expensive than manual surgical stapling devices. In
addition, the iDrive is reusable, easy to use, cost effective, and less
wasteful, potentially leading to savings for hospitals and health networks.
The iConsole is a proprietary wireless device that communicates directly with
the iDrive during surgical procedures to output specific auditory and visual
reference information via its speaker and liquid crystal display. Outputs
provide surgeons with important information regarding calibration, firing, and
instrument and reload type, allowing surgeons to make real-time, critical
decisions that may ultimately lead to an improved patient outcome.
The iDrive and iConsole combination represents a dynamic technology solution
which is designed to enable the incorporation of important functional
enhancements. PMI intends to aggressively pursue and implement a variety of key
enhancements, which ultimately could lead to offering surgeons the world's first
wireless computer mediated platform with unprecedented capabilities such as
wireless video processing, Internet access, a patient record interface and
controlled tissue compression software.
"The iDrive and iConsole are the latest examples of Power Medical Interventions'
commitment to pioneering continued innovation in the surgical arena. These
instruments will deliver critical advantages to surgeons offering single handed
use, flexibility, and access to remote anatomical sites. PMI's Intelligent
Surgical Instruments have applications in open surgery, minimally invasive
surgery and the emerging field of natural orifice translumenal endoscopic
surgery (NOTES)," said Michael Whitman, president and chief executive officer of
PMI. "At the same time, these new instruments are designed to reduce healthcare
costs and improve hospitals' operational efficiency. Our hospital customers will
now be able to acquire PMI's advanced stapling technology at a greatly reduced
cost. The iDrive/iConsole combination offers a single power unit to drive all of
our Intelligent Surgical Instruments, eliminating the need to purchase multiple
power units. The cost savings is passed along to our hospital customers.
Furthermore, the reusable and autoclavable nature of these instruments plays a
key role in helping to reduce medical waste, offering additional meaningful
benefits to our hospital customers."
About PMI's Intelligent Surgical Instruments(tm)
PMI has developed a suite of state-of-the-art wireless Intelligent Surgical
Instruments(tm) that are used by surgeons for cutting, stapling and tissue
manipulation in a variety of procedures in open surgery, minimally invasive
surgery (MIS) and in the emerging field of natural orifice translumenal
endoscopic surgery (NOTES). PMI designed these first-of-their-kind devices to
improve medical outcomes by offering superior consistency, repeatability,
compressive force, access to anatomical sites, ergonomics and ease of use
compared to conventional endomechanical devices. As a result, Intelligent
Surgical Instruments have the potential to become the standard of care in an
increasing number of procedures.
About Power Medical Interventions, Inc.
Power Medical Interventions is the world's only provider of computer-assisted,
power-actuated surgical cutting and stapling products. PMI's state-of-the-art
wireless Intelligent Surgical Instruments(tm) are revolutionizing and expanding
minimally invasive surgery applications and enabling novel surgical procedures
to benefit surgeons, patients, hospitals and healthcare networks. To learn more
about Power Medical Interventions, Inc. and its products, please visit
www.pmi2.com.
Safe Harbor Statement
Statements included in this press release, which are not historical in nature,
are forward-looking statements made pursuant to the safe harbor provisions of
the Private Securities Litigation Reform Act of 1995. Statements relating to the
future financial performance of the Company are subject to many factors
including, but not limited to, the ability of the Company's products, including
the iDrive Intelligent Power Unit(tm), detachable Intelligent Surgical
Instruments and iConsole, to achieve broad market acceptance; the Company's
ability to raise additional capital; the Company's ability to restructure its
debt; the possibility of incurring additional losses in the foreseeable future;
the Company's inability to further identify, develop and achieve commercial
success for new products and technologies; the Company's difficulty in
increasing production to provide customers with adequate supply; the Company's
inability to improve gross margins; loss of the Company's key suppliers; the
Company's inability to manage continued growth; inability to remediate the
Company's internal weakness over financial reporting and achieve and maintain
effective internal control over financial reporting; failure in the Company's
training efforts; the risk of product liability claims connected with the use of
the Company's products; adverse effects or risks relating to the Company's sales
in international markets; the Company's inability to comply with the covenants
of its 7% Senior Convertible Secured Notes; the Company's inability to satisfy
the requirements of the FDA and other regulatory agencies; loss of key
personnel; lack of third party coverage and reimbursement for the Company's
products; risk of loss of the Company's key manufacturing facility, and other
risks detailed in the Company's Securities and Exchange Commission filings,
including the Company's Report on Form 10-Q for the quarterly period ended March
31, 2009 and Annual Report on Form 10-K for the year ended December 31, 2008.
Such statements are based upon the current beliefs and expectations of the
Company's management and are subject to significant risks and uncertainties.
Actual results may differ from those set forth in the forward-looking
statements. When used in this press release the terms "anticipate," "believe,"
"estimate," "expect," "may," "objective," "plan," "possible," "potential,"
"project," "will" and similar expressions identify forward-looking statements.
The forward-looking statements contained in this press release are made as of
the date hereof, and the Company does not undertake any obligation to update any
forward-looking statements, whether as a result of future events, new
information or otherwise.
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CONTACT: Power Medical Interventions, Inc.
Brian M. Posner, Chief Financial Officer
267-775-8100
Vida Communication
Media:
Tim Brons
415-675-7402
tbrons@vidacommunication.com
Investors:
Stephanie Diaz
415-675-7401
sdiaz@vidacommunication.com
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